May 2013

COVER

SPECIAL REPORT - Prefilled Syringes & Parenteral Contract Manufacturing: Improving for Flexibility & Customization

Special Feature: Contributor Cindy H. Dubin speaks with prefilled syringe manufacturers as well as contract parenteral manufacturers who share their thoughts about the delivery challenges associated with high-viscous, high-volume formulations.

FEATURES

ADVANCED DELIVERY DEVICES - Important Considerations in the Delivery of Large-Volume & Viscous Drugs

Kevin Cancelliere, MS, believes that as the trend toward self-administration continues, the need for careful consideration of primary container design, interaction with the drug product, method of administration, and end-user needs becomes even more critical.

AUTOLOGOUS CELL THERAPIES - Development of Autologous Cell Therapies: Keys to Clinical & Commercial Success

Ronnda L. Bartel, PhD, Tod Borton, and Brian S. Hampson review how Aastrom Biosciences has developed the innovative processes necessary to reduce risk throughout the manufacturing process. The company is now preparing for future commercialization for its investigational therapy derived from a patient's own bone marrow stem cells.

EXCIPIENT UPDATE - Delivering Gastric-Resistant Functionality Via a Colorless Top Coat

Philip J. Butler and Thorsten Cech investigate the gastric-resistant functionality obtained by applying a clear, two-component MAE coating formulation onto a tablet sub-coated with a pigmented instant-release coating and investigate the impact of hydrophilic and lipophilic plasticizers on the film characteristics of MAE-based coating formulations.

EXECUTIVE INTERVIEW - SNBL, Ltd.: Innovation in Drug Delivery Enabled Through a Unique Business Model

Drug Development Executive: Dr. Shunji Haruta, Founder of NDS (Nasal Delivery Systems) Division and Executive Officer, SNBL, Ltd., discusses how NDS Division and its powder nasal delivery platform, µco System, fit into a new paradigm.

FORMULATION DEVELOPMENT - A Call for Collaboration to Meet the Bioavailability Challenge

Marshall Crew, PhD, President & CEO, Agere Pharmaceuticals, Inc., begins his multiple-part series discussing today's most challenging issues in solubility.

FORMULATION DEVELOPMENT - Trends & Opportunities in Particle Design Technologies - Life Sciences & Biopharma in the Spotlight

Frost & Sullivan Analyst, Cecilia Van Cauwenberghe, MS, examines the observed trends in particle design and engineering technologies, as well as the main factors and opportunities driving the principal technological advances in the biopharmaceutical industry.

M*A*S*H

John A. Bermingham explains how it is incumbent upon CEOs and their management teams to triage all functional areas of the company when in times of trouble and the investors are looking for a quick fix to stop the bleeding.

MANAGEMENT INSIGHT - Rook to D7: Game Theory in the Pharma Industry

Derek G. Hennecke continues with part 4 of a new 6-part series offering an overview of this year's best business books with insights into what they can teach the Pharma industry.

MARKET FORECASTING - Monte Carlo-Based Forecasting: How to Deal With Uncertainty

Jemma Lampkin and Gerard Loosschilder, PhD, show how Monte Carlo-based forecasts are better at handling uncertainties, turning them into valuable tools for product managers and marketers engaged in strategic business planning.

TRANSDERMAL DELIVERY - New Frontiers in Transdermal Drug Delivery

Kenneth B. Kirby and Chandan A.S. Alam, MD, are part of a team at Transdermal Delivery Solutions Corp. (TDSC) that has been leveraging its patented technology to develop a unique patchless, metered pump, spray-on drug delivery system and products.

SPECIAL REPORT - Prefilled Syringes & Parenteral Contract Manufacturing: Improving for Flexibility & Customization

Special Feature: Contributor Cindy H. Dubin speaks with prefilled syringe manufacturers as well as contract parenteral manufacturers who share their thoughts about the delivery challenges associated with high-viscous, high-volume formulations.